Assessing the Prognosis of TACE in Combination With PD-1/PD-L1 Inhibitors and Molecular Target Therapies for HCC by Using Clinical and Imaging Biomarkers

• Conditions: Hepatocellular Carcinoma

• Registration Number: NCT05278195
• Lead Sponsor: Zhongda Hospital

Brief Summary

The purpose of this study is to id

transarterial chemoembolization (TACE) in combination with immune checkpoint inhibitors (ICIs) and molecular targeted therapies in patients with hepatocellular carcinoma (HCC) .

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-03
• Study First Submitted: 2022-03-04
• Study First Submitted QC: 2022-03-04
• Last Update Submitted: 2022-03-04
• Study First Posted: 2022-03-14
• Last Update Posted: 2022-03-14
• Study Start: 2022-04-01
• Primary Completion: 2022-12-01
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1. Has a diagnosis of HCC confirmed by radiology, histology, or cytology;

2. Has not received any previous systemic therapy for HCC (including chemotherapy, molecularly targeted therapy, immunotherapy);

3. Both PD-1/PD-L1 inhibitors and anti-angiogenesis drugs patients received only include marketed drugs but are not limited to HCC approval;

4. TACE was performed up to 3 months after the first PD-1/PD-L1 inhibitor/anti-angiogenic drug treatment or within 1 month before treatment;

5. Received at least 1 cycle of PD-1/PD-L1 inhibitor/anti-angiogenic drug combination therapy after TACE treatment；

6. Has repeated measurable intrahepatic lesions according to RECIST v1.1;

Exclusion Criteria

1. Cholangiocarcinoma, fibrolamellar, sarcomatoid hepatocellular carcinoma, and mixed hepatocellular/cholangiocarcinoma subtypes(confirmed by histology, or pathology) are not eligible;
2. Unable to meet criteria of combination timeframe described above;
3. Missing follow-up data;

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall Survival(OS)	up to approximately 2 years	The OS is defined as the time from the initiation of any combination treatment to death due to any cause.

Secondary Outcome Measures

Name	Time	Method
Accuracy	baseline	Defined by a confusion matrix of sensitivity and specificity to true positives and true negatives.
Sensitivity	baseline	The sensitivity of the radiomics artificial intelligence model for identifying optimal candidates among patients who treated TACE in combination with PD-1/PD-L1 inhibitors and molecular target therapy will be calculated.
Specificity	baseline	The specificity of the radiomics artificial intelligence model for identifying optimal candidates among patients who treated TACE in combination with PD-1/PD-L1 inhibitors and molecular target therapy will be calculated.
The area under curve (AUC) of Receiver Operating Characteristic (ROC) curves of the radiomics artificial intelligence mode	baseline	The area under curve (AUC) of Receiver Operating Characteristic (ROC) curves of the radiomics artificial intelligence model for identifying optimal candidates among patients who treated TACE in combination with PD-1/PD-L1 inhibitors and molecular target therapy will be calculated.

Trial Locations

Locations (1)

Zhongda Hospital, Southeast University; 🇨🇳 Nanjing, Jiangsu, China